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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Comp-Position - 00860010555637

Comp-Position height adjustable and width adjustable geriatric tilt-in-space chair
L.P.A. Médical Inc
O-07
In Commercial Distribution

  • 00860010555637 ()


  • Assistive ergonomic chair, manually-adjusted

Optimum - 00860010555620

Optimum Posturopedic tilt-in-space geriatric chair
L.P.A. Médical Inc
1400
In Commercial Distribution

  • 00860010555620 ()


  • Assistive ergonomic chair, manually-adjusted

Evolution - 00860010555613

Evolution tilt-in-space pedal chair with central push-rims
L.P.A. Médical Inc
S-250
In Commercial Distribution

  • 00860010555613 ()


  • Walking chair, non-foldable

Dyn-Ergo - 00860010555606

Geriatric tilt-in-space pedal chair
L.P.A. Médical Inc
S-150
In Commercial Distribution

  • 00860010555606 ()


  • Walking chair, non-foldable

Hemaprep - 00860010522301

Blood smear instrument automated; Microscope slide maker IVD; portable, light weight (1 pound); no external power required.
J P Gilbert Company Inc
756300
In Commercial Distribution

  • 00860010522301 ()

  • Height: 5.4 Inch
  • Depth: 6.3 Inch
  • Width: 3.5 Inch
756300

  • Microscope slide maker IVD

Humero Tech - 00860010519912

The Humero Tech C1 HD is an updated version of the Humero Tech C1 to better withstand strength and conditioning activities in addition to rehabilitation. The C1 HD is a seated apparatus capable of completing a vast number of shoulder rehabilitation and strengthening exercises. This device has the capability to be utilized in low level rehabilitation and strengthening progressing to more functional and dynamic activities. The Humero Tech C1 HD has an intended us of assisting with improving the strength, active range of motion, and motor control of the postoperative status, or when a deficit in power is noted. The device collects data and tracks range of motion to evaluate progress over time.
Titin Km Biomedical Corp.
C1 HD
In Commercial Distribution

  • 00860010519912 ()
A2-0000

  • Virtual-display rehabilitation system, passive-support, upper-limb

Humero Tech - 00860010519905

The Humero Tech C1 has been developed as a solution for the current limitations with shoulder rehabilitation. The C1 is a seated apparatus capable of completing a vast number of shoulder rehabilitation and strengthening exercises. This device has the capability to be utilized in low level rehabilitation and strengthening progressing to more functional and dynamic activities. The Humero Tech C1 has an intended use of assisting with improving the strength, active range of motion, and motor control of the shoulder complex. Furthermore, the indications for use will be any individual suffering from a shoulder pathology, including postoperative status, or when a deficit in power is noted. The device collects data and tracks range of motion to evaluate progress over time.
Titin Km Biomedical Corp.
C1
In Commercial Distribution

  • 00860010519905 ()
A1-0000

  • Virtual-display rehabilitation system, passive-support, upper-limb

Fertility Solutions - 00860010518199

Spermocytometer® sperm counting chambers. Box of 25 disposable slides each containing 2 single use counting chambers. 20 micron deep fixed coverslip glass chambers. Requires the use of an eyepiece reticle. https://www.fertilitysolutions.com/product-category/spermocytometer
Fertility Solutions, Inc.
SA400
In Commercial Distribution

  • 86001051819986 ()
  • 00860010518199 ()

  • Depth: 20 Micrometer
SA400

  • Microscope counting chamber IVD

AQC - 00860010518182

Sperm Morphology Virtumorph® Quality Control - 1 fifty cell Virtumorph® printed virtual semen morphology smear and 1 Pap stained and coverslipped glass sperm morphology smear, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-morphology-quality-control
Fertility Solutions, Inc.
AQC305
In Commercial Distribution

  • 00860010518182 ()
AQC305

  • Sperm morphology/viability control IVD

AQC - 00860010518175

Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
In Commercial Distribution

  • 00860010518175 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control
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